Study of LJP 394 in Lupus Patients With History of Renal Disease (ASPEN)

This study has been terminated.
(Interim efficacy analysis indicated it would be futile to continue study.)
Sponsor:
Information provided by:
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00089804
First received: August 13, 2004
Last updated: March 30, 2009
Last verified: March 2009

August 13, 2004
March 30, 2009
October 2004
February 2009   (final data collection date for primary outcome measure)
To determine whether abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a history of SLE renal disease. Weekly administration with a 52-week treatment duration. [ Time Frame: Time to event (12 months fixed treatment duration) ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00089804 on ClinicalTrials.gov Archive Site
To determine whether treatment with abetimus sodium is more effective than placebo in delaying the time to Major SLE flare; and to determine whether treatment with abetimus sodium (LJP 394) is more effective than placebo in reducing proteinuria. [ Time Frame: 12 month fixed treatment duration ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Study of LJP 394 in Lupus Patients With History of Renal Disease
A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Lupus Erythematosus, Systemic
  • Lupus Nephritis
  • Drug: abetimus sodium (LJP 394) and/or placebo solution
    300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks
  • Drug: abetimus sodium (LJP 394)
    900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.
  • Drug: Phosphate-buffered saline
    A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks
    Other Name: Placebo, normal saline
  • Active Comparator: 1
    300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly
    Intervention: Drug: abetimus sodium (LJP 394) and/or placebo solution
  • Active Comparator: 2
    900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
    Intervention: Drug: abetimus sodium (LJP 394)
  • Placebo Comparator: 3
    A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly
    Intervention: Drug: Phosphate-buffered saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
943
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Systemic Lupus Erythematosus (SLE)
  • Active SLE renal disease within past 4 years.
  • Males or females between 12 and 70 years old.
  • Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.
  • Ability to have weekly intravenous (IV) administration of study treatment.

Exclusion Criteria:

  • Active SLE renal disease within past 3 months prior to entering study.
  • Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
  • Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.
  • Use of rituximab within 6 months prior to entering study.
  • Current abuse of drugs or alcohol.
Both
12 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belarus,   Brazil,   Bulgaria,   Czech Republic,   Georgia,   Germany,   Hong Kong,   Hungary,   India,   Indonesia,   Italy,   Korea, Republic of,   Lebanon,   Malaysia,   Mexico,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Serbia,   Slovakia,   Spain,   Sri Lanka,   Taiwan,   Thailand,   Ukraine
 
NCT00089804
LJP 394-90-14
Yes
Michael J. Tansey, Chief Medical Officer, La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company
Not Provided
Study Director: Michael J Tansey, MD, Ph.D. Chief Medical Officer, La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP